BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 units of the BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile (Item 431183) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The affected product was distributed worldwide, including to numerous U.S. states. The recall involves multiple lot numbers and products can be identified by their lot numbers or UDI (Unique Device Identifier) numbers listed in the recall details.
The recall does not specify a remedy or instructions for consumers who may have obtained this product. Consumers who believe they may have one of the affected units should contact Biomet, Inc. directly using the lot or UDI numbers provided to determine if their product is included in the recall and to learn what actions, if any, are appropriate.
Written by software from the official notice below. Not reviewed by a lawyer.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Reason for recall: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. Distribution: Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nev Quantity: 230,001 Lot/code info: ***Lot Numbers*** 082090, 651800, 982380, 809020, 320900, 623230, 623240, 630160, 636040, 823140, 234220, 370430, 556610, 047420, 846270, 270160, 374980, 382930, 508920, 419300, 189910, 404850, 844540, 474080, 009850, 467650, 297630, 280110, 913710, 913720, 916350, 039560, 364320, 858200, 557640, 990120, 328020, 102150, 486050, 903730, 295200, 906770, 906940, 907000, 109280, 952910, 627830, 496520, 972210, 038630, 112390, 496530, 627840, 292590, 401300, 441840, 362300, 683630, 966950, 074190, 184490, 829820, 949770, 591260, 988950, 322780, 757440, 827110, 827090, 229610, 404850R, 892790, 673830, 229600, 827060, 757460, 892730, 892750, 757430, 757450, 827080, 628570, 808650, 628560, 808640, 884540, 884530, 757420, 757490, 765160, 456220, 456250, 456260, 456280, 456300, 456350, 456190, 456370, 483850, 483950, 638590, 638640, 478960, 478970, 478990, 479020, 479040, 483830, 483860, 483880, 483900, 483920, 483940, 483960, 483970, 483990, 569060, 569080, 569090, 569110, 569130, 569140, 569160, 569210, 569240, 570120, 570130, 638550, 638560, 638580, 638600, 638620, 638630, 638650, 638670, 638680, 638690, 638700, 638710, 765090, 765110, 765120, 765150, 765180, 765190, 765210, 765230, 765240, 765260, 765270, 569100, 988390, 483910, 638540, 979260, 981280, 989340, 988640 989850, ***UDI Numbers*** (01)00880304521254(17)170728(10)082090, (01)00880304521254(17)171228(10)651800, (01)00880304521254(17)171221(10)982380, (01)00880304521254(17)171226(10)809020, (01)00880304521254(17)180118(10)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.